Mabylon reports positive phase Ia results in MY006 peanut allergy trial and initiates phase Ib patient part of the study

Mabylon AG, a leader in the discovery and development of human-derived, half-life extendetoday reported preliminary positive phase Ia data demonstrating a favourable safety profile of its lead candidate MY006 in an ongoing first-in-human trial. Mabylon also announced the initiation of dosing of individuals with peanut allergy in the phase Ib part of the study. The company’s antibodies are designed to neutralize disease-relevant allergens, thereby preventing allergic reactions.

The ongoing randomized, quadruple-blinded, placebo-controlled phase Ia/Ib study evaluates the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary clinical activity of MY006 in healthy volunteers and peanut-allergic adolescents and adults.

As of the end of April 2026, dosing of healthy volunteers in Part A of the study has been completed for all subjects. While the trial remains blinded and database lock has not occurred yet, preliminary blinded data indicate that MY006 has been well tolerated to date, with no treatment-related serious adverse events or adverse events of severe intensity reported.

In addition, the blinded PK profile of MY006 closely matches Mabylon’s preliminary PK model and demonstrates linear dose proportionality as well as an extended half-life, supporting further clinical development. Based on the available safety and PK data, the study’s Safety Monitoring Committee (SMC) recommended initiation of Part B of the trial. Part B is conducted in peanut-allergic patients and first patients have entered screening in early May 2026. Part B of the study is designed to explore early signals of clinical activity and desensitization potential using double-blinded, placebo-controlled food challenges at different timepoints following MY006 administration.

“The initiation of the peanut allergy patient part of the study represents an important milestone for Mabylon,” said Dr. Niccolò Pengo, PhD, chief scientific officer of Mabylon. “The preliminary safety and PK profiles observed so far support our confidence in the potential of MY006 as a differentiated prophylactic approach for peanut allergy.”

Mabylon’s lead compound, MY006, is a subcutaneous multi-specific antibody treatment designed to address peanut allergy, one of the most severe and potentially life-threatening food allergies worldwide with a high unmet medical need. The compound is based on patient-derived antibodies and is designed to prevent allergic reactions, including anaphylaxis, in individuals with peanut allergy with only a few subcutaneous injections per year.

Mabylon also announced progress with its second development program, MY010, targeting allergies to tree pollen of the Fagales order. The multi-specific antibody is designed to neutralize birch pollen allergens as well as closely related, clinically relevant tree pollen allergens from oak, hazel, alder, and other Fagales species. The program recently completed cell line development and has now entered GMP manufacturing in preparation for GLP toxicology studies, IND filing, and subsequent clinical development.

In parallel, Mabylon is establishing a dedicated Clinical Development Advisory Board for MY010, bringing together leading experts in the allergy and immunology field. In addition to the CHF 30 million capital raised in 2025, the company has secured the necessary funding to advance both MY006 and MY010 through the next stages of clinical development.

“Our goal is to build a leading antibody-based allergy therapeutics pipeline with multiple differentiated product candidates addressing severe allergic diseases,” said Dr. Alcide Barberis, chief executive officer of Mabylon AG. “Our multi-specific drug candidates are designed to neutralize several key allergens simultaneously, potentially enabling broad allergen protection with only a few administrations per year. The progress of both MY006 and MY010 demonstrates the strength and scalability of our platform.”

Mabylon is a clinical-stage Swiss biotechnology company harnessing the therapeutic potential of naturally occurring human antibodies to treat allergies, inflammation, and neurodegenerative diseases. Human-derived antibodies have superior therapeutic potential compared to antibodies derived from conventional sources, such as humanized animal models or artificial libraries.

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